Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families

NCT03097458 | Completed

• 1 other identifier: PP-16-07
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A parental cancer diagnosis challenges the family's stability and the parent-child relationship. It may impact the children's well-being, so that about one third of them develop clinically relevant levels of psychological distress. Psycho-oncological family-based counselling programs have been shown to elevate children's and parents' well-being. However, there is still a dearth of familial health services in Switzerland, which has also been recognized by the Swiss National Cancer Program (2011-2017). This study aims to implement and evaluate a short-term family counselling intervention at the Cancer Center of the University Hospital Basel. The primary objective of the study is the enhancement of adjustment to the parental cancer diagnosis. The study seeks secondary to determine the feasibility of the short-term counselling Intervention.

Conditions

Psychological Adjustment; Cancer

Keywords

Counselling for Families; Parental cancer; Psychological distress and adjustment

Outcome Measures

Primary Outcomes (5)

• Change of children's quality of life on the health-related quality of life questionnaire (KINDL)

  Enhancement of children's quality of life from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

  6 weeks (change between baseline and week 6)

• Change of children's behavioral-emotional functioning on the Strengths and Difficulties Questionnaire (SDQ)

  Enhancement of children's behavioral-emotional functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

  6 weeks (change between baseline and week 6)

• Change of parent's mental health on the Hospital Anxiety and Depression Scale (HADS)

  Enhancement of parent's mental health from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

  6 weeks (change between baseline and week 6)

• Change of family functioning on the Family Adaptability and Cohesion Evaluation Scale (FACES IV)

  Enhancement of family functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

  6 weeks (change between baseline and week 6)

• Change of relationship quality on the relationship questionnaire (Partnerschaftsfragebogen PFB)

  Enhancement of relationship quality from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.

  6 weeks (change between baseline and week 6)

Secondary Outcomes (5)

• Number of participants willing to participate in the counselling

  Through study completion, an average of 2 years

• Sociodemographic characteristics (i.e. age, gender, education) of the participants willing to participate in the counselling with the sociodemographic questionnaire

  Through study completion, an average of 2 years

• Medical history characteristics (i.e. cancer diagnosis, cancer treatment) of the participants willing to participate in the counselling with the medical history questionnaire

  Through study completion, an average of 2 years

• Dropout rate during the recruitment and intervention procedure

  Through study completion, an average of 2 years

• Client satisfaction on the Client Satisfaction Questionnaire (CSQ-8)

  Measures assessed after 6 weeks

Study Arms (2)

Counselling

EXPERIMENTAL

short-term counselling for families

Behavioral: Short-term Counselling for Families

Wait-list control group

NO INTERVENTION

Wait-list control group

Interventions

Short-term Counselling for Families BEHAVIORAL

Counselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist.

Counselling

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature
• Diagnosis of any kind of cancer, inclusive relapse, within the last year with an expected survival of at least 8 months
• Married, cohabiting or single parent
• At least one child between 1-5 - 18 years
• German speaking

You may not qualify if:

• The diagnosis is more than 1 year ago
• Diagnosed patients (parent) not living with their children
• Diagnosed patients without custody of their children

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• propatient Forschungsstiftung: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Corinne Urech, Dr. phil.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized wait-list control design (cross-over).

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 31, 2017
• Study Start: February 4, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)